MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LATITUDE PROGRAMMING SYSTEM; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

Model Number 3300

Device Problems Device Sensing Problem (2917); Key or Button Unresponsive/not Working (4063)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2020

Event Type  malfunction  

Event Description

It was reported that this programmer did not show a mv value when checking amplitudes on the lead with the psa; however, when the lead was connected to the device, the measurements were displayed.Additionally, the touch screen occasionally became unresponsive and could only be resolved by rebooting the programmer.No adverse patient effects were reported.The programmer remained in service.

Manufacturer Narrative

Although no device has been returned for analysis, we have received reports of similar events where the latitude programmer screen became unresponsive to touch inputs during use.In most cases, the programmer required a system reboot to complete testing.Representatives from our post market quality assurance, manufacturing, and design assurance groups are actively investigating this unresponsive touchscreen behavior with the latitude programmer to determine the root cause.Based on our initial investigation, this behavior is most likely design-related.

• Brand Name: LATITUDE PROGRAMMING SYSTEM
• Type of Device: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): PLEXUS CORPORATION; 2400 millbrook dr; buffalo grove IL 60089
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16914384
• MDR Text Key: 315040249
• Report Number: 2124215-2023-23393
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910077/S159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3300
• Device Catalogue Number: 3300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1